NIZORAL Shampoo (2019)
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Περιεχόμενα
Name of the medicinal product
Nizoral 2% shampoo.
Qualitative and quantitative composition
Ketoconazole 2% w/w (each gram contains 20 mg). For a full list of excipients, see 6.1.
Pharmaceutical form
Pink viscous shampoo.
Therapeutic indications
Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff and seborrhoeic dermatitis. Treatment of tinea (pityriasis) ...
Posology and method of administration
For topical administration. Ketoconazole shampoo 2% is for use in adolescents and adults: Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash. ...
Contraindications
Known hypersensitivity to ketoconazole or any of the excipients.
Special warnings and precautions for use
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral 2% shampoo, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled ...
Overdose
In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
Pharmacodynamic properties
Pharmacotherapeutic group: Imidazole and triazole derivatives ATC Code: D01AC08 Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad ...
Pharmacokinetic properties
Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% shampoo on the scalp. Plasma levels were detected after topical administration of Nizoral 2% shampoo ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
List of excipients
Sodium lauryl ether sulfate Disodium monolauryl ether sulphosuccinate Coconut fatty acid diethanolamide Laurdimonium hydrolysed animal collagen Macrogol 120 methyl glucose dioleate Sodium chloride Concentrated ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
High density polyethylene bottles, containing 120 ml shampoo.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0139
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 April 1988 Date of renewal of authorisation: 24 June 2008
Date of revision of the text
08 February 2019
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